Actively Recruiting
Practical Clinical Study of Dual-targeting BCMA-CD19 CAR-T Cell Therapy for Extramedullary Infiltration in Refractory/Relapsed Multiple Myeloma
Led by Beijing GoBroad Hospital · Updated on 2025-11-26
18
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Beijing GoBroad Hospital
Lead Sponsor
S
Shanghai Liquan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a dual-targeting BCMA-CD19 CAR-T cell therapy for patients with relapsed or refractory multiple myeloma who have extramedullary infiltration. This phase 1, multicenter, open-label, single-arm trial aims to evaluate the safety of this dual-target CAR-T treatment. The study will primarily assess dose-limiting toxicities and adverse events occurring within one month after treatment to better understand the therapy's safety profile. Participants will receive a lymphodepletion chemotherapy regimen consisting of fludarabine and cyclophosphamide for about 3 to 5 days before the CAR-T cell infusion. The dual-target BCMA-CD19 CAR-T cells will be infused 48 hours after completing chemotherapy. This single treatment approach focuses on targeting two specific markers on cancer cells to address extramedullary lesions in multiple myeloma. During the study, participants will be closely monitored for safety and treatment effects, including the type and frequency of toxicities within the first month. Researchers will also measure outcomes such as remission rates over 90 days and survival outcomes up to two years. Safety evaluations, organ function tests, and assessments of disease markers will be conducted regularly to understand the treatment's impact over time. The trial will enroll up to 18 participants aged 18 to 75 years and includes follow-up for up to two years to assess long-term outcomes.
CONDITIONS
Brief Title
Dual-target BCMA-CD19 CAR-T Cell Therapy for RR/MM With Extramedullary Infiltration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers willing to participate and comply with study requirements
- Age between 18 and 75 years, any gender
- Diagnosis of relapsed or refractory multiple myeloma with measurable extramedullary lesions
- Positive BCMA expression in bone marrow, cerebrospinal fluid tumor cells, or tumor tissue
- Adequate organ function including cardiac, liver, kidney, coagulation, oxygen saturation, and lung function
- Female of childbearing age with negative pregnancy test; males willing to use contraception for 1 year post-treatment
- ECOG performance status of 2 or less
- Expected survival time greater than 3 months
You will not qualify if you...
- Pregnant or breastfeeding women
- Uncontrolled active infections
- Uncontrolled active autoimmune diseases
- Unresolved adverse reactions from prior treatments above grade 1
- Active graft-versus-host disease in allogeneic transplant recipients
- Positive tests for HBV-DNA, HCV antibody with RNA, syphilis antibody, or HIV antibody
- Allergy or intolerance to fludarabine or cyclophosphamide
- Known symptomatic non-plasma cell central nervous system diseases
- Uncontrolled cardiovascular or cerebrovascular diseases within 6 months
- Recent myocardial infarction or coronary artery bypass within 6 months
- Significant ventricular arrhythmias or unexplained syncope
- History of severe non-ischemic cardiomyopathy
- Untreated or concurrent malignancies within past 5 years
- Inability or unwillingness to comply with study protocol
- Previous use of the same CAR-T vector structure in treatment
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week including chemotherapy and CAR-T cell infusion
Participants receive lymphodepletion chemotherapy followed by dual-targeting BCMA-CD19 CAR-T cell infusion.
1 chemotherapy period lasting 3-5 days and 1 CAR-T cell infusion visit
Duration - Up to 2 years
Participants are monitored for dose-limiting toxicities, adverse events, and treatment response up to 2 years.
Regular visits during the first 30 days and periodic assessments up to 2 years
Trial Site Locations
Total: 1 location
1
Shanghai Liquan Hospital
Shanghai, China
Actively Recruiting
Research Team
Y
Yao Yao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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